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New treatment option for Rectal Neoplasms
Official title Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
ClinicalTrials.gov ID: NCT05943444
What this study is testing
- What it's testing
- The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men or women, aged between 18 and 75 years;
- Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
- No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before...
- Suitable for anal preservation surgery discussed by MDT;
- Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
You likely can't join if
- Previous history of malignant colorectal tumors;
- Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
- Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
- Multiple primary tumors;
- History of other malignancy;
- Participation in other clinical trials within the previous 4 weeks of enrollment;
See the full eligibility criteria
- Men or women, aged between 18 and 75 years;
- Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
- No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
- Suitable for anal preservation surgery discussed by MDT;
- Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
- R0 resection is expected technically;
- Provision of written informed consent.
- Previous history of malignant colorectal tumors;
- Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
- Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
- Multiple primary tumors;
- History of other malignancy;
- Participation in other clinical trials within the previous 4 weeks of enrollment;
- ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
- Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
- History of serious mental disorders;
- Women in pregnancy or lactation period;
- Uncontrolled infection before operation;
- Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.